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Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit Families plus Standard Medical Care
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin Dependent Diabetes Mellitus, family therapy, adolescents, regimen adherence, metabolic control

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a current hemoglobin A1c(HbA1c) of >9.0%
  • an average HbA1c of >9.0% during the past year
  • reside in the metro Detroit tri-county area
  • diagnosed with Type 1 diabetes for at least one year
  • aged 10-17
  • patient of Children's Hospital of Michigan Diabetes Clinic

Exclusion Criteria:

  • severe mental impairment/thought disorder
  • Active suicidality
  • Active homicidality
  • Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.

Sites / Locations

  • Children's Hospital of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fit Familes plus Standard Medical Care

Standard Medical Care

Arm Description

Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.

Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.

Outcomes

Primary Outcome Measures

Metabolic Control: Hemoglobin A1c (HbA1c)
retrospective measure of blood glucose control, encompasses the previous 2-3 months

Secondary Outcome Measures

DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Quality of life
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control

Full Information

First Posted
September 4, 2014
Last Updated
May 31, 2017
Sponsor
Wayne State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02243072
Brief Title
Home-Based Interventions for Adolescents With Type 1 Diabetes
Acronym
R34
Official Title
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.
Detailed Description
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial. The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Insulin Dependent Diabetes Mellitus, family therapy, adolescents, regimen adherence, metabolic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fit Familes plus Standard Medical Care
Arm Type
Experimental
Arm Description
Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.
Arm Title
Standard Medical Care
Arm Type
No Intervention
Arm Description
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.
Intervention Type
Behavioral
Intervention Name(s)
Fit Families plus Standard Medical Care
Intervention Description
Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
Primary Outcome Measure Information:
Title
Metabolic Control: Hemoglobin A1c (HbA1c)
Description
retrospective measure of blood glucose control, encompasses the previous 2-3 months
Time Frame
Change from Baseline at 7 months, Change from Baseline at 9 months
Secondary Outcome Measure Information:
Title
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Description
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Time Frame
Change from Baseline at 7 months, Change from Baseline at 9 months
Title
Quality of life
Description
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
Time Frame
Change from Baseline at 7 months, Change from Baseline at 9 months
Title
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Description
The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
Time Frame
Change from Baseline at 7 months, Change from Baseline at 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a current hemoglobin A1c(HbA1c) of >9.0% an average HbA1c of >9.0% during the past year reside in the metro Detroit tri-county area diagnosed with Type 1 diabetes for at least one year aged 10-17 patient of Children's Hospital of Michigan Diabetes Clinic Exclusion Criteria: severe mental impairment/thought disorder Active suicidality Active homicidality Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A Ellis, Ph.D
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Home-Based Interventions for Adolescents With Type 1 Diabetes

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